Many medical conditions related to the head of a patient may be treated by the use of medical devices that are externally applied to the head of the patient.
One set of medical conditions, e.g., trauma, tumor, disease, are known to cause the brain to swell, increasing intracranial pressure (ICP). In many situations this increase in ICP may be life threatening, requiring a surgical procedure known as a decompressive craniotomy. In this procedure, a large segment of cranial bone, known as the bone flap, is removed from the cranium. The removal of the bone flap relieves the intracranial pressure by allowing the brain to temporarily swell through the hole made in the cranium.
The bone flap is stored, with the intent of returning it to the cranium, once the swelling has subsided and the patient has stabilized, typically 4-6 weeks after the procedure. The bone flap is stored either by surgically inserting it into the abdomen, or by freezing it. Until the bone flap is replaced, it may be desirable to protect the portion of the head comprising the portion where the bone flap has been removed.
One option is to provide a external plate that is affixed to the scalp of the patient as described in a copending patent application Serial No. filed on even date herewith and assigned to a common assignee. The contents of that application are incorporated herein by reference.
Accordingly, it is desirable to provide a method of manufacturing a medical device for external application to the head of a subject.